Body cavities are drained or fed with different types of tubes. Examples of such cavities include the urinary bladder cavity, the gastric or intestinal cavity and the post-operative cavity. Also, cystic ducts and gall bladder spaces and other such cavities are drained or fed with rigid or flexible tubes. The flexible tubes are made of biocompatible polymer materials such as silicone, polyethylene, etc. These tubes have an external part (out of the body or the organ) and an internal part. The external part of these tubes are exposed to accidental pulling forces which may cause the tube to dislodge out of the body.
Different methods of tube fixation to the body exist. External fixation (skin contact fixation) of the tube includes: fastening the tube to the skin with adhesive tapes and/or suturing the tube to the skin with surgical threads.
Internal fixation methods include:
balloon inflation of the tube tip to enlarge its diameter and increase its pull-out force resistance;
use of a catheter tip which flares outward to a large diameter by flexing of the catheter wall. Examples of such devices are known as Malleot or Petzer catheters. In those systems, fins which are normally flared open form the enlarged tip of the catheter. A constant force is required to press the flares concentrically to insert or remove the catheter.
The main advantage of the present balloon fixation system over the Malleot and Petzer catheters is the fact that the balloon catheter is inserted and removed in substantially the same low profile diameter whereas with the Malleot and Petzer catheters a substantial pull-out force is required to close the flare and enable catheter removal. During pull-out of the prior art catheters, the flares apply a radial and shearing force on the body tissue surrounding the tube which may cause unnecessary pain and trauma.
Another disadvantage of the Malleot and Petzer flared catheter fixation systems is the low fixation force of the tube within the body. This fixation force is limited because of the resulting desirably small pull-out force to remove the tube. This pull-out force, as mentioned, may cause trauma to the tissue.
The main disadvantage of the balloon fixation method is its relatively complicated insertion procedure requiring the need for a syringe to inflate the balloon. Also, the balloon""s large area of contact with the body tissue can cause substantial tissue irritability.
A means for remotely opening and closing flares in the body will allow for easy insertion and removal of a catheter with a flare-type fixation system. Also, remotely closing the flares, before removing the catheter, allow flares with high fixation forces to be used without causing any trauma to the tissue during removal.
The invention relates to a system for catheter fixation to a body by enlarging or reducing a catheter tip diameter during insertion to or removal from the body. More particularly, the invention also relates to a medical grade flexible polymer tube which is used mainly as a drainage tube but is not limited to drainage systems. It may also be used for urological intra-urethral sphincters, plugs or devices or may be used as urethral, ureteral, bronchial or esophageal catheters.
In another embodiment of the invention, the system is used for closing body organ holes such as atrio-ventricular septal defects, arterial punctures, gastric or intestinal leakage from a fistula, or any passage or hole to be obstructed.
The invention enables the enlargement (and reduction) of the catheter tip diameter when located in the body by an external manipulation thereby fixing the catheter in place. Another manipulation, external to the body or organ, is used to return the tip diameter to its original small diameter size prior to catheter removal.
The invention also relates to a catheter, tube or plug with a distal-end tip that is made up of one or more fins which can flare outwardly thereby increasing the diameter of the catheter tip and holding the catheter in position in the body.
The invention also relates to a push-tube which is used to force the fins to flare open.
The invention also relates to a system which selectively locks the fins in the stressed or flared-open position.
The invention also relates to equipment which aids in the installation of a catheter in the human body and its removal from the body.
All these embodiments will become clear in the detailed description of the invention and the attached figures.